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- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- EPFHearing Aid, Group And Auditory Trainer2Product Code
- NEACement, Ear, Nose And Throat2Product Code
- ESDHearing Aid, Air Conduction1Product Code
- ESELarynx, Artificial (Battery-Powered)1Product Code
- ESHPolymer, Ent Synthetic-Pife, Silicon Elastomer, Polyethylene, Polyurethane2Product Code
- ESXTack, Sacculotomy (Cody Tack)2Product Code
- ESZTube, Shunt, Endolymphatic2Product Code
- ETAReplacement, Ossicular Prosthesis, Total2Product Code
- ETBProsthesis, Partial Ossicular Replacement2Product Code
- K130512NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON STAPES PROSTHESIS2Cleared 510(K)
- K112616NITIBOND STAPES PROSTHESIS, NITIPLAST STAPES PROSTHESIS2Cleared 510(K)
- K080070K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESES2Cleared 510(K)
- K063374NITINOL LOCKING INCUDO-STAPEDIAL JOINT, ANGULAR PISTON, PISTON, MALLEUS PISTON, PORP AND FOOTPLATE SHOE2Cleared 510(K)
- K061853GRACE MEDICAL ADJUSTABLE AND FIXED LENGTH PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESES2Cleared 510(K)
- K060518PARTIAL OSSICULAR REPLACEMENT PROSTHESES2Cleared 510(K)
- K033554SMART OFFSET STAPES PISTON; SMART ISJ PROSTHESIS2Cleared 510(K)
- K021479CLIP PISTON AWENGEN, MODEL# 1006 805 - 1006 8612Cleared 510(K)
- K013573CLIP PARTIAL PROSTHESIS-TITANIUM DRESDEN, MODEL 1002 250-2572Cleared 510(K)
- K010442KURZ ANGULAR PISTON-TITANIUM PROSTHESIS, MODELS 1006 600, 1006 601, 1006 602, 1006 650, 1006 651, 1006 6522Cleared 510(K)
- K003214SMITH & NEPHEW PISTONS2Cleared 510(K)
- K002737SMITH & NEPHEW PORPS & TORPS2Cleared 510(K)
- K002897TITANIUM MIDDLE EAR PROSTHESES2Cleared 510(K)
- K002464SMITH & NEPHEW OFF-CENTERED PORP2Cleared 510(K)
- K002221KURKZ K-PISTON TITANIUM STAPEDIAL PROSTHESIS, MODEL 1006 103-1006 1702Cleared 510(K)
- K001142AUDIO TECHNOLOGIES S:R.12Cleared 510(K)
- K000858WEHRS INCUS-STAPES2Cleared 510(K)
- K000256CAP PORP, CAP TORP2Cleared 510(K)
- K993234MICROMEDICS S&T PARTIAL OSSICULAR REPLACEMENT PROSTHESIS2Cleared 510(K)
- K992839SOCKET STAPES PISTON W/O LOOP, SCHOBEL, SCHOBEL-CAUSSE2Cleared 510(K)
- K991394STAPES PROSTHESES2Cleared 510(K)
- K990923TUBINGEN TITANIUM PROSTHESIS (TTP) VARIO, MODELS AERIAL 1004 010 & BELL 1002 0102Cleared 510(K)
- K981045EXMOOR TEFLON LOOP REPLACEMENT PROSTHESIS2Cleared 510(K)
- K974365MILLS INCUS HA SLEEVE2Cleared 510(K)
- K973356K-PISTON WITH BAND HOOK /ANGULAR PISTON2Cleared 510(K)
- K972815PARTIAL/TOTAL/POROUS POLYETHYLENE OSSICULAR REPLACEMENT2Cleared 510(K)
- K972737CAUSSE PISTON2Cleared 510(K)
- K972734PARTIAL OSSICULAR REPLACEMENT PROSTHESIS (PORP)2Cleared 510(K)
- K972492BELL PROSTHESIS (PARTIAL)2Cleared 510(K)
- K964909ESTERM MALLEUS TOTAL AND PARTIAL MIDDLE EAR PROSTHESIS2Cleared 510(K)
- K962564RICHARDS TOTAL/PARTIAL PROSTHESIS2Cleared 510(K)
- K964798PARTIAL OSSICULAR REPLACEMENT PROSTHESIS2Cleared 510(K)
- K963752PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESIS2Cleared 510(K)
- K945105POLY/PLATINUM WIRE PISTON2Cleared 510(K)
- K955613MISTEN MEDICAL PARTIAL OSSICULAR REPLACEMENT PROSTHESIS2Cleared 510(K)
- K954517TREBAY PARTIAL RECTRANGULAR HEADS, MORETZ CAM, INCUS/STAPEDIAL JOINT & STRAIGHT INCUS STRUT2Cleared 510(K)
- K952481RICHARDS PORP2Cleared 510(K)
- K950984HAPES MALLEABLE INCUS STAPES2Cleared 510(K)
- K950886HAPEX PORP2Cleared 510(K)
- K950887HAPEX INCUS2Cleared 510(K)
- K950885HAPEX MALLEABLE PORP2Cleared 510(K)
- K945107POLY-WIRE PISTON2Cleared 510(K)
- K945104MICROMED PARTIAL REGULAR AND PARTIAL OFFSET2Cleared 510(K)
- K945108POLY PISTON2Cleared 510(K)
- K925443INCUDOSTAPEDIAL JOINT2Cleared 510(K)
- K915120TEF/PLATINUM PISTON2Cleared 510(K)
- K915121TEF/WIRE PISTON2Cleared 510(K)
- K913287H/A PARTIAL - REGULAR & H/A PARTIAL - OFFSET2Cleared 510(K)
- K913285PTFE PISTON2Cleared 510(K)
- K910685WEHRS INCUS AND INCUS-STAPES PROSTHESES2Cleared 510(K)
- K913619CERAVITAL MIDDLE EAR IMPLANT2Cleared 510(K)
- K895814MICROTEK PISTON & WIRE PROSTHESES2Cleared 510(K)
- K893134APACERAM OSSICULAR PROSTHESIS2Cleared 510(K)
- K883727BUCKET PROSTHESIS PORP2Cleared 510(K)
- K872112XOMED PLATINUM WIRE TEFLON PISTION2Cleared 510(K)
- K870766PROSTHESIS WIRE2Cleared 510(K)
- K861369INCUS/STAPES PROSTHESIS2Cleared 510(K)
- K860460MICROTEK STAINLESS STEEL PISTON2Cleared 510(K)
- K844961INCUS PROSTHESIS2Cleared 510(K)
- K841353CAUSSE SPONGE BOAT2Cleared 510(K)
- K832540DRUMTO STAPES PROSTHESIS2Cleared 510(K)
- K823483STAINLESS STEEL PISTONS2Cleared 510(K)
- K823429FISCH MODIFIED TEF-WIRE PISTON2Cleared 510(K)
- K823439CAUSSE TEF-PISTON2Cleared 510(K)
- K823440MCGEE MODIFIED STAINLESS STEEL PISTON2Cleared 510(K)
- K802873SHEA LOCKING BAIL PROSTHESIS2Cleared 510(K)
- K802431SCHURING OSSICLE CUP & COLUMELLA PROSTH.2Cleared 510(K)
- K760434TRAPEZE PLATINUM RIBBON LOOP, OTOLOGY2Cleared 510(K)
- K760437CAUSSE MODIFIED TEFLON PISTON, OTOLOGY2Cleared 510(K)
- K760435PISTON, PLATINUM TEFLON, OTOLOGY IMPLANT2Cleared 510(K)
- ETCMold, Middle-Ear2Product Code
- ETDTube, Tympanostomy2Product Code
- ETWCalibrator, Hearing Aid / Earphone And Analysis Systems2Product Code
- EWLProsthesis, Laryngeal (Taub)2Product Code
- FWNProsthesis, Larynx (Stents And Keels)2Product Code
- JAZProsthesis, Facial, Mandibular Implant2Product Code
- JOFPolymer, Ent Synthetic, Porous Polyethylene2Product Code
- JXSBlock, Cutting, Ent, Sterile1Product Code
- JXTCrimper, Wire, Ent, Sterile1Product Code
- JXWDie, Wire Bending, Ent, Sterile1Product Code
- JXXForceps, Wire Closure, Ent, Sterile1Product Code
- JXYJig, Piston Cutting, Ent, Sterile1Product Code
- JXZPunch, Gelfoam, Sterile1Product Code
- JYAScissors, Wire Cutting, Ent, Sterile1Product Code
- JYBVise, Ossicular Finger, Sterile1Product Code
- KHJPolymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)2Product Code
- KHLHearing Aid, Master2Product Code
- KLWMasker, Tinnitus2Product Code
- KLZTube, Shunt, Endolymphatic With Valve2Product Code
- KQLTube, Tympanostomy With Semi-Permeable Membrane2Product Code
- LBLTube, Tympanostomy, Porous Polyethylene2Product Code
- LBMPorous Polyethylene Ossicular Replacement2Product Code
- LBNReplacement, Total Ossicular, Prosthesis, Porous, Polyethylene2Product Code
- LBPReplacement, Ossicular (Stapes) Using Absorbable Gelatin Material2Product Code
- LDGKit, Earmold, Impression1Product Code
- LRBFace Plate Hearing Aid1Product Code
- LREInstrument, Prosthesis Modification For Ossicular Replacement Surgery, Sterile1Product Code
- LWFDilator, Nasal1Product Code
- LXBHearing Aid, Bone Conduction2Product Code
- LZIDevice, Assistive Listening2Product Code
- MAHHearing Aid, Bone Conduction, Implanted2Product Code
- MCKDevice, Voice Amplification2Product Code
- MIXSystem, Vocal Cord Medialization2Product Code
- NHBPolymer, Ear, Nose And Throat, Synthetic, Absorbable2Product Code
- NIXHearing Aid, Air Conduction, Transcutaneous System2Product Code
- NNNCrimper, Wire, Ent, Non-Sterile1Product Code
- NNOJig, Piston Cutting, Ent, Non-Sterile1Product Code
- NNPDie, Wire Bending, Ent, Non-Sterile1Product Code
- NNQForceps, Wire Closure, Ent, Non-Sterile1Product Code
- NNRBlock, Cutting, Ent, Non-Sterile1Product Code
- NNSInstrument, Prosthesis Modification For Ossicular Replacement Surgery, Non-Sterile1Product Code
- NNTPunch, Gelfoam, Non-Sterile1Product Code
- NNUScissors, Wire Cutting, Ent, Non-Sterile1Product Code
- NNVVise, Ossicular Finger, Non-Sterile1Product Code
- OGSMyringotomy Procedure Kit2Product Code
- OSMHearing Aid, Air Conduction With Wireless Technology2Product Code
- PFOActive Implantable Bone Conduction Hearing System2Product Code
- PLKTympanic Membrane Direct Contact Hearing Aid2Product Code
- QDDSelf-Fitting Air-Conduction Hearing Aid2Product Code
- QUFHearing Aid, Air-Conduction, Over The Counter1Product Code
- QUGHearing Aid, Air-Conduction With Wireless Technology, Over The Counter2Product Code
- QUHSelf-Fitting Air-Conduction Hearing Aid, Over The Counter2Product Code
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
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- OphthalmicReview Panel
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- PathologyReview Panel
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HAPEX MALLEABLE PORP
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K950885
- 510(k) Type
- Traditional
- Applicant
- SMITH & NEPHEW RICHARDS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/15/1995
- Days to Decision
- 15 days
- Submission Type
- Summary